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. 2010 Nov 10;2010(11):CD003940. doi: 10.1002/14651858.CD003940.pub3

FDA 305A.

Trial name or title Randomized, controlled trial of SCH 56592 oral suspension versus fluconazole suspension in the treatment of oropharyngeal candidiasis (OPC) in HIV positive patients
Methods Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and re monitored for safety and efficacy of study treatment.
Participants Estimated enrolment: 300
Inclusion criteria: 18 yrs or older; HIV positive; Have thrush (OC); agree to sexual abstinence of use effective barrier methods of birth control; Able to take study medication and return to clinic
Interventions  
Outcomes  
Starting date August 1998
Contact information  
Notes Study completed. No publications provided.
Clincal Trials.gov: NCT00002446